Formation Bio · 1 day ago
Director, Formulation Development
New York, United States
Full-time
Hybrid
Director/Executive
$242K/yr - $290K/yr
10+ years expFormation Bio is a tech and AI driven pharma company focused on revolutionizing drug development. The Director, Formulation Development will lead formulation development and manufacturing for drug candidates, providing technical leadership and collaborating across various functions to ensure successful program outcomes.
Artificial Intelligence (AI)BiotechnologyClinical TrialsHealth CareMedicalPharmaceutical
Responsibilities
Technical Leadership: Provide technical leadership for development and manufacturing of phase appropriate formulations for Formation Bio programs. (pre-IND to Phase 2/3) This is primarily focused on development of solid oral dosage forms, but could include solid state characterization, pre-formulation and alternate dosage forms, as well as the development of formulations for injection
Cross-Functional Collaboration: Partner with other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory, clinical pharmacology and project management to support short and long term program objectives
CRO and CDMO Management: Oversee and manage drug product vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards
Documentation: Author and review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations
Regulatory submissions: Author, and contribute to regulatory submissions, including INDs, BLAs, and other regulatory dossiers
Due-Diligence Support: As part of Formation Bio’s strategy to in-license programs and develop to point of inflection, support the Business Development Team with assessment of potential new assets from a technical and financial risk standpoint
Qualification
Required
MS or PhD in pharmaceutical sciences, chemical engineering, organic chemistry, or related discipline
Minimum of 10 years' technical experience in formulation development positions and manufacture in the pharmaceutical/biotech industry
Experience with the development and manufacturing of solid oral dosage forms for small molecule programs
Demonstrated experience in selecting and collaborating with domestic and international CROs, CDMOs and consultants
Manufacturing experience and a good understanding of cGMP requirements
Proficient in writing RFPs, protocols, reports, and regulatory documents
Ability to travel domestically and internationally up to 25% of the time
Preferred
Experience of enabled formulation development (spray drying, HME) to support preclinical to early development programs
Experience in development of other dosage forms and combination products
Solid state characterization and pre-formulation development experience
Understanding of biopharmaceutical fundamentals
Benefits
Equity
Comprehensive benefits
Generous perks
Hybrid flexibility
Company
Formation Bio
Formation Bio is a drug development company that strives to provide treatments to patients faster by reimagining clinical trials.
51-200 employees
H1B Sponsorship
Formation Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
Funding
Current Stage
Late StageTotal Funding
$528MKey Investors
Andreessen Horowitz
2024-06-26Series D· $372M
2021-09-30Series C· $156M
2018-10-15Series Unknown
Leadership Team
Benjamine Liu
CEO and Co-Founder
Linhao Zhang
Co-Founder and COO
Recent News
Spark Capital
2026-01-07
BioWorld Financial Watch
2025-12-19
2025-12-16
Company data provided by crunchbase